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阿维A治疗重度外阴硬化性苔藓:一项双盲、安慰剂对照研究。

Acitretin in the treatment of severe lichen sclerosus et atrophicus of the vulva: a double-blind, placebo-controlled study.

作者信息

Bousema M T, Romppanen U, Geiger J M, Baudin M, Vähä-Eskeli K, Vartiainen J, Vuopala S

机构信息

Department of Dermato-Venereology, Academic Hospital/Dijkigt, Rotterdam, The Netherlands.

出版信息

J Am Acad Dermatol. 1994 Feb;30(2 Pt 1):225-31. doi: 10.1016/s0190-9622(94)70021-4.

DOI:10.1016/s0190-9622(94)70021-4
PMID:8288782
Abstract

BACKGROUND

Promising results have been reported from treatment with oral retinoids in patients with severe lichen sclerosus et atrophicus (LSA) of the vulva.

OBJECTIVE

The aim of our study was to determine the efficacy of acitretin (20 to 30 mg/day) for 16 weeks in LSA.

METHODS

Seventy-eight patients were enrolled into a multicenter, randomized, placebo-controlled, double-blind trial. The primary measure of efficacy was the "responder" rate based on the assessment of characteristic clinical features of LSA of the vulva (pruritus, burning, atrophy, hyperkeratosis, and secondary features such as erosions, ulcers, edema, or lichenification) and on the extent of the lesions.

RESULTS

From the 46 patients eligible for efficacy analysis, a significantly higher number of responders was observed in the acitretin-treatment group (14 of 22 patients) as compared with the placebo-treatment group (6 of 24 patients). Typical retinoid adverse reactions were observed in all patients receiving active drug.

CONCLUSION

Acitretin is effective in treating women with severe LSA of the vulva.

摘要

背景

口服维甲酸治疗重度外阴硬化性苔藓(LSA)患者已报道有前景良好的结果。

目的

我们研究的目的是确定阿维A(20至30毫克/天)治疗16周对LSA的疗效。

方法

78例患者纳入一项多中心、随机、安慰剂对照、双盲试验。疗效的主要衡量指标是“有效率”,基于对外阴LSA特征性临床特征(瘙痒、烧灼感、萎缩、角化过度以及糜烂、溃疡、水肿或苔藓化等次要特征)的评估和病变范围。

结果

在46例符合疗效分析条件的患者中,与安慰剂治疗组(24例中的6例)相比,阿维A治疗组(22例中的14例)观察到显著更多的有效者。所有接受活性药物治疗的患者均观察到典型的维甲酸不良反应。

结论

阿维A对外阴重度LSA女性有效。

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